Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

This study is not yet open for participant recruitment.
Verified February 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Zachary Kuhlmann, DO, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01786330
First received: February 5, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.


Condition Intervention
Postpartum Hemorrhage
Pain
Device: Procare abdominal binder
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Hemoglobin concentration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values.


Secondary Outcome Measures:
  • SF-MPQ2 Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain assessment scale


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.
Device: Procare abdominal binder
Active Comparator: Control
Group receives standard of care
Other: Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cesarean section at term (at least 39 weeks gestation) scheduled in advance
  • Singleton gestation confirmed by ultrasound in the current pregnancy
  • Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
  • None of these pregnancy complications in the current pregnancy:

    1. bleeding disorder or use of anticoagulants other than low-dose heparin
    2. abnormal placenta (placenta previa or accrete)
    3. Preoperative hemoglobin less than 10 mg/dL
    4. Chorioamnionitis (intrauterine infection)
  • No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
  • Able to read English and understand spoken English

Exclusion Criteria:

  • Onset of labor prior to time when the cesarean was scheduled
  • Complications during performance of cesarean or discovered during cesarean:

    1. placenta accreta, increta, or percreta
    2. vasa previa
    3. cesarean hysterectomy required for severe hemorrhage
    4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786330

Contacts
Contact: Liesa Hopper 316-293-1880 lhopper@kumc.edu

Locations
United States, Kansas
Kansas School of Medicine-Wichita Not yet recruiting
Wichita, Kansas, United States, 67214
Contact: Liesa Hopper    316-293-1880    lhopper@kumc.edu   
Principal Investigator: Zachary Kuhlmann, DO         
Sub-Investigator: Jamie H Gustafson, MD         
Sub-Investigator: Linda Frazier, MD, MPH         
Wesley Medical Center Not yet recruiting
Wichita, Kansas, United States, 67214
Contact: Liesa Hopper    316-293-1880    lhopper@kumc.edu   
Sponsors and Collaborators
Zachary Kuhlmann, DO
Investigators
Principal Investigator: Zachary Kuhlmann, DO University of Kansas
  More Information

No publications provided

Responsible Party: Zachary Kuhlmann, DO, Principal Investigator, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01786330     History of Changes
Other Study ID Numbers: 220121565, 12-049
Study First Received: February 5, 2013
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Puerperal Disorders
Hemorrhage
Pain, Postoperative
Postpartum Hemorrhage
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Uterine Hemorrhage

ClinicalTrials.gov processed this record on April 15, 2014